Laparoscopic Surgery for Severe Recto-vaginal Endometriosis

March 25, 2019 updated by: Mr Andrew Kent, Royal Surrey County Hospital NHS Foundation Trust

Laparoscopic Surgery for Severe Recto-vaginal Endometriosis: A Prospective Cohort Study

To determine the quality of life following the radical excision of recto-vaginal endometriosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing surgery for severe endometriosis with bowel involvement were asked to complete pre-operative and post operative questionnaires at 2, 6 and 12 months, then 5, 10, 15, 20 and 25 years post operatively.

Quality of life measured using the EHP-30 and EQ-5D questionnaires. Bowel symptoms were measured using GIQLI. Dysmenorrhoea, dyspareunia, dyschezia and chronic pain were measured using a visual analogue scale.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Recruiting
        • Royal Surrey County Hospital NHS Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients who underwent surgery for endometriosis with bowel involvement.

Description

Inclusion Criteria:

  • All women undergoing planned surgery for severe endometriosis with bowel involvement.

Exclusion Criteria:

  • Patients who declined to complete questionnaires for whatever reason and/or have their anonymous data analysed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery for severe endometriosis
Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement
Procedure: Surgery for severe endometriosis
Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life measured using the Endometriosis Health Profile 30 (EHP-30) and EuroQol-5 dimension (EQ-5D) questionnaires.
Time Frame: 1 year post operative
Recruitment is continuous
1 year post operative
Bowel symptoms measured using the Gastro-intestinal Quality of Life Index (GIQLI).
Time Frame: 1 year post operative
Recruitment is continuous
1 year post operative
Dysmenorrhoea measured using a visual analogue scale (VAS).
Time Frame: 1 year post operative
Recruitment is continuous
1 year post operative
Dyspareunia measured using a visual analogue scale (VAS).
Time Frame: 1 year post operative
Recruitment is continuous
1 year post operative
Dyschezia measured using a visual analogue scale (VAS).
Time Frame: 1 year post operative
Recruitment is continuous
1 year post operative
Chronic pain measured using a visual analogue scale (VAS).
Time Frame: 1 year post operative
Recruitment is continuous
1 year post operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life measured using the EHP-30 and EQ-5D questionnaires.
Time Frame: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Bowel symptoms were measured using GIQLI.
Time Frame: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Dysmenorrhoea measured using a visual analogue scale.
Time Frame: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Dyspareunia measured using a visual analogue scale.
Time Frame: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Dyschezia measured using a visual analogue scale.
Time Frame: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
Chronic pain measured using a visual analogue scale.
Time Frame: 2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative
2 months, 6 months, 5 years, 10 years, 15 years, 20 years, 25 years follow up post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Andrew Kent, TD MD FRCOG, Royal Surrey County Hospital/Nuffield Health Guildford Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (ANTICIPATED)

January 1, 2025

Study Completion (ANTICIPATED)

January 1, 2040

Study Registration Dates

First Submitted

June 6, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (ESTIMATE)

June 15, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15DEV0009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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